Sessions Court Cannot Take Cognisance Under Drugs & Cosmetics Act

Source: Bombay High Court

Why in News?

Justice N.J. Jamadar of the Bombay High Court, in M/s. C.B. Healthcare & Ors. v. Union of India (2026), allowed a writ petition filed by a pharmaceutical firm and its partners, quashing criminal proceedings initiated under Section 27(d) of the Drugs & Cosmetics Act, 1940.  

• The Court held that a Sessions Court cannot take direct cognisance of such offences without committal by a Magistrate under Section 193 of the CrPC (213 of BNSS) and additionally found serious procedural lapses that rendered continuation of the prosecution an abuse of process.

What was the Background of M/s. C.B. Healthcare & Ors. v. Union of India (2026) Case? 

• A Drugs Inspector drew a sample from a government hospital store in 2016, which was subsequently reported to be "not of standard quality." 
• Following sanction, a complaint was filed before the Special Judge at Silvassa, who directly issued process against the petitioners without committal by a Magistrate. 
• The petitioners challenged this before the Bombay High Court, contending that a Special Judge, being a Sessions Court, lacked jurisdiction to take direct cognisance. 
• Separately, the petitioners pointed to significant procedural violations — including delay in testing the sample in breach of Rule 45 of the Drugs Rules, 1945, and failure to send a portion of the sample to the manufacturer for possible reanalysis. 
• By the time the complaint was filed, the shelf life of the drug had already expired, rendering the right to seek reanalysis entirely illusory.

What were the Court's Observations? 

• On Cognisance by Sessions Court: The Court held that Section 32(2) of the Drugs & Cosmetics Act, while mandating trial by a Court not inferior to a Court of Session, contains no express provision permitting direct cognisance. In the absence of such a provision, the bar under Section 193 CrPC applies — requiring committal by a Magistrate before the Sessions Court can assume jurisdiction. 
• On the Notification Designating a Special Court: The Court rejected the respondent's reliance on a notification designating a Special Court, holding that such designation does not override the committal requirement, particularly when the offences in question did not fall within those for which special courts were empowered to take direct cognisance. 
• On Procedural Lapses: The Court noted an inordinate delay in testing the sample, in violation of Rule 45 of the Drugs Rules, 1945. It further held that failure to send a portion of the sample to the manufacturer deprived the petitioners of their valuable statutory right to seek reanalysis. 
• On Abuse of Process: The cumulative effect of these procedural infirmities — delay in testing, failure to notify the manufacturer, and expiry of shelf life before complaint — was held to have rendered continuation of the prosecution an abuse of process.

What is Section 213 BNSS? 

• Section 213 of the Bharatiya Nagarik Suraksha Sanhita, 2023 (BNSS), which corresponds to Section 193 of the Criminal Procedure Code (CrPC), provides that no Court of Session shall take cognizance of any offence as a Court of original jurisdiction unless the case has been committed to it by a Magistrate. 
• This provision establishes the fundamental principle that Sessions Courts derive their jurisdiction to try cases through the committal process conducted by Magistrates.

What is the Drugs and Cosmetics Act, 1940? 

Background & Purpose: 

• Enacted to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India. 
• Replaced the earlier Dangerous Drugs Act and aimed to ensure the safety, efficacy, and quality of drugs available to the public. 
• Administered jointly by the Central Government and State Governments. 

Structure: 

• Divided into multiple Chapters dealing with drugs, cosmetics, and Ayurvedic, Siddha, and Unani medicines separately. 
• Supported by the Drugs and Cosmetics Rules, 1945, which provide detailed procedural and technical requirements. 

Key Definitions: 

• "Drug" includes medicines for internal or external use, substances used for diagnosis, and articles intended to affect body structure or function. 
• "Cosmetic" means any article intended for use on the human body for cleansing, beautifying, or altering appearance. 
• "Manufacture" includes any process involved in making, altering, ornamenting, finishing, or otherwise treating a drug. 

Regulatory Authorities: 

• Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body headed by the Drugs Controller General of India (DCGI). 
• State Drug Authorities handle licensing and enforcement at the state level. 
• Drug Inspectors are empowered to inspect, sample, and seize drugs. 

Chapter IV – Manufacture, Sale & Distribution: 

• Prohibits manufacture, sale, or distribution of drugs that are misbranded, adulterated, or spurious. 
• Section 18(a)(vi) prohibits manufacture or sale in contravention of Chapter IV or Rules made thereunder. 
• Manufacturers must comply with Schedule M (Good Manufacturing Practices) and Schedule U (manufacturing record requirements). 
• Licenses are mandatory for manufacture and sale of drugs. 

Scheduled Substances & Records: 

• Schedule M lays down standards for premises, equipment, and documentation for drug manufacturing. 
• Schedule U prescribes the particulars to be shown in manufacturing, testing, and distribution records. 
• Habit-forming substances like Pseudoephedrine are subject to stricter record-keeping and oversight. 

Offences & Punishments: 

• Section 27 prescribes punishments for various offences including manufacture of spurious or adulterated drugs, with imprisonment ranging from one year to life, depending on the nature of the offence. 
• Section 27(d) punishes contravention of Chapter IV or Rules with imprisonment of not less than one year and up to two years. 
• Section 28-A prescribes imprisonment of up to one year for failure to maintain records or furnish information under Section 18-B. 
• Section 32(2) mandates that no Court inferior to a Court of Session shall try offences under Chapter IV. 

Cognizance & Trial: 

• Offences under Chapter IV are exclusively triable by a Sessions Court and cannot be tried by a Magistrate. 
• Section 36-A, which allows summary trial by a JMFC for lesser offences, does not apply to Chapter IV offences due to the overriding mandate of Section 32(2). 
• Special Courts under Section 36-AB may also be constituted for speedy trial of drug offences. 

Inspection & Enforcement Powers: 

• Drug Inspectors have wide powers to enter and inspect premises, take samples, seize stocks, and examine records. 
• Section 22(1)(cca) empowers inspectors to check compliance with record-keeping requirements. 
• Refusal to produce records or furnishing false information is itself an offence under the Act. 

Significance: 

• The Act serves as the backbone of drug regulation in India, ensuring that only safe and effective medicines reach consumers. 
• It has been periodically amended to address emerging challenges such as counterfeit drugs, online pharmacies, and new drug categories. 
• Compliance with the Act is essential for all pharmaceutical manufacturers, importers, and distributors operating in India.